Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3800](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3800) → HQT — Shell, Scleral

# HQT · Shell, Scleral

_Ophthalmic · 21 CFR 886.3800 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT

## Overview

- **Product Code:** HQT
- **Device Name:** Shell, Scleral
- **Regulation:** [21 CFR 886.3800](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3800)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K970327](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT/K970327.md) | SCLERAL SHELL | Southwest Artificial Eyes, Inc. | Jul 7, 1997 | SESE |
| [K970320](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT/K970320.md) | SCLERAL SHELL | Xavier A. Guerra, Ocularist, Inc. | Jul 7, 1997 | SESE |
| [K904961](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT/K904961.md) | ARTIFICIAL SCLERAL SHELL | Midwest Eye Laboratories, Inc. | Aug 30, 1991 | SESE |
| [K855105](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT/K855105.md) | SIMMONS SHELL | Mira, Inc. | Mar 31, 1986 | SESE |

## Top Applicants

- Midwest Eye Laboratories, Inc. — 1 clearance
- Mira, Inc. — 1 clearance
- Southwest Artificial Eyes, Inc. — 1 clearance
- Xavier A. Guerra, Ocularist, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQT)

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